IRAY Pluto0002XW Digital Wireless Intraoral X-Ray Sensor User Manual
- June 9, 2024
- IRAY
Table of Contents
Pluto0002XW Digital Wireless Intraoral X-Ray Sensor
Pluto0002XW Digital Wireless Intraoral X-Ray Sensor User
Manual
Product Information
The Pluto0002XW is a digital wireless intraoral X-ray sensor
produced by iRay Technology Co., Ltd. It is designed to capture
high-quality X-ray images of the teeth and surrounding oral
structures for diagnostic and treatment purposes in dental offices.
The product comes with an internal battery that should not be
disposed of with domestic or commercial waste. Proper disposal of
the product and its internal battery is required to ensure the
safety of the environment.
Product Usage Instructions
Before installing and operating the product, it is important to
read the user manual and accompanying documents carefully and pay
attention to all safety precautions to prevent personal injury or
product damage. The installation, debugging, addition,
modification, and maintenance of this product should only be
carried out by qualified professionals. Only qualified and
authorized personnel can operate this product.
The device must be stored and operated in a specified
environment and maintained by professional maintenance personnel
under safe and operable conditions. It is recommended to use only
computers and image display monitors recommended in the manual to
ensure proper functioning of the product.
The disposal of sheaths and other medical waste should follow
the normal dental office procedure for biomedical waste to prevent
the spread of illness and disease. When disposing of the product,
follow the procedure that conforms to the laws and regulations in
your area. The built-in battery must be removed and disposed of by
a qualified professional.
For details on product installation and use, consult your sales
representative and local dealer. Failure to follow the instructions
in the manual may result in abnormality, product damage, and
personal injury for which iRay Technology Co., Ltd. will not be
held responsible.
Roentgenography, image acquiring, image processing, image
reading, and image data storage must be performed in accordance
with the law of the country where the product is being used. The
user and operator are responsible for maintaining the privacy of
image data acquired from the product.
Dentists assume the responsibility for the faulty diagnosis, for
which iRay Technology Co., Ltd. bears no liability.
User Manual
Pluto0002XW
Digital Wireless Intraoral X-Ray Sensor
IMAGING THE FUTURE
E
Ver.: A01 Doc. ID: 179-201-02 Date: 06/01/2022
To Customers
To Customers
Thank you for choosing the Pluto0002XW Digital Wireless Intraoral X-Ray Sensor
(hereinafter referred to as Pluto0002XW) from iRay Technology Co., Ltd.
(hereinafter referred to as iRay Technology) as your X-ray imaging solution.
This user manual describes how to install, use and maintain this product, how
to integrate this product into your system, and how to operate the iDetector
provided with the Pluto0002XW. The illustrations in this manual are for
explanatory and demonstration purposes only. Actual product may vary due to
product enhancement. Please read this manual thoroughly before using the
product and retain it for future reference.
Copyright
© iRay Technology Co., Ltd. All rights reserved. Under copyright laws, no part
of this publication may be reproduced in any form or by any means without the
written permission of iRay Technology Co., Ltd.
Trademarks
The name “iRay” and iRay logo are registered trademarks of iRay Technology
Co., Ltd.
Caring for the Environment
Product Disposal
This symbol indicates that this product and its internal battery should not be
disposed of with your domestic or commercial waste. Disposal of this product
in an unlawful manner may have a negative impact on health and the
environment. When disposing of the product, be sure to follow the procedure
that conforms to the laws and regulations in your area. Please note that the
built-in battery must be removed and disposed of by a qualified professional.
Disposal of Biomedical Waste
Dispose of sheaths and other medical waste following the normal dental office
procedure for biomedical waste. Improper disposal of those can lead to the
spread of illness and disease.
i
Pluto0002XW User Manual
To Customers
For Your Safety
To prevent personal injury or product damage, be sure to read the user manual, familiarize yourself with all
accompanying documents carefully and pay attention to all safety precautions before installing and operating
the product. Follow exactly the guidelines described in this manual when installing and using this product.
The installation, debugging, addition, modification, and maintenance of this product can only be carried out
by qualified professionals.
Only qualified and authorized personnel can operate this product.
The device must be stored and operated in a specified environment and maintained by professional
maintenance personnel under safe and operable conditions.
Use only computers and image display monitors recommended in this manual.
Disclaimer
For details on product installation and use, please consult your sales representative and local dealer.
In no event shall iRay be reliable for any abnormality, product damage, and personal injury caused when the
instructions of this manual are not followed.
In no event shall iRay be reliable for any damage, loss, or injury arising from fire, earthquake, any action or
accident by a third party, any intentional or negligent action by users, any trial usage, or other usages under
abnormal conditions.
In no event shall iRay be reliable for any damage, loss, or injury arising from moving, alteration, inspection,
or repair of the product by a person other than an authorized service engineer by iRay.
In no event shall iRay be reliable for any damage or loss arising from the use of any options or consumable
products other than those dedicated as original iRay products.
Roentgenography, image acquiring, image processing, image reading, and image data storage must be
performed in accordance with the law of the country where the product is being used.
In no event shall iRay be reliable for loss of image data for any reason while using the product. The user and
operator are responsible for maintaining the privacy of image data acquired from the product.
Dentists assume the responsibility for the faulty diagnosis, for which iRay bears no liability.
Symbols
Due to updates and constantly improving performance, the design and specifications of the device and the contents of this manual are subject to change without prior notice.
The symbols used throughout this manual are classified as follows for better comprehension of their meanings. Take special care to heed all warning symbols inside this manual and obey the instructions they contain.
Pluto0002XW User Manual
ii
To Customers
!
WARNING
!
CAUTION
Denotes a potentially hazardous situation that, if not avoided, will result in
severe injury, death, or substantial product damage
Denotes a potentially hazardous situation that, if not avoided, could result
in minor or moderate injury or product damage
PROHIBITED
Denotes that you should NEVER perform the indicated action.
NOTE
Indicates supplement important information or advice that helps you make better use of your device
REFERENCE
Denotes “refer to the documents attached to the CD” or “refer to other Sections of this manual for information”
Abbreviations
Abbreviation
AC AED AP CMOS DC DQE DR EMC EMI FTP IP ISO IT LAN LED MTF PC ROI RF SAR SDK
SID
Explanation
Alternating Current Automatic Exposure Detection Access Point Complementary
Metal-Oxide-Semiconductor Transistor Direct Current Detective Quantum
Efficiency Digital Radiography Electro Magnetic Compatibility Electromagnetic
Interference File Transfer Protocol Internet Protocol International
Standardization Organization Information Technology Local Area Network Light
Emitting Diode Modulation Transfer Function Personal Computer Range of
Interest Radio Frequency Specific Absorption Rate Software Development Kit
Source Image Distance
iii
Pluto0002XW User Manual
Abbreviation
SN SNR UDI UI UPS WL WLAN WW
Explanation
Serial Number Signal to Noise Ratio Unique Device Identification User
Interface Uninterrupted Power Supply Window Level Wireless Local Area Networks
Window Width
To Customers
Pluto0002XW User Manual
iv
Table of Contents
Table of Contents
CHAPTER 1 SAFETY PRECAUTIONS ……………………………………………………………………………………………….1 1.1
Operation and Storage Environment ………………………………………………………………………………………………………. 1
1.2 Device, Interface, Battery, and Cable
……………………………………………………………………………………………………… 2 1.3 Handling of Device Failures and
Serious Incidents ………………………………………………………………………………….. 3 1.4 Inspection,
Cleaning, and Disinfection …………………………………………………………………………………………………….3
CHAPTER 2 REGULATORY INFORMATION ………………………………………………………………………………….. 5 2.1
Symbols ……………………………………………………………………………………………………………………………………………… 5 2.2 Safety
Standards for Medical Device ……………………………………………………………………………………………………… 6 2.2.1
Medical Device Classification ……………………………………………………………………………………………………. 6 2.2.2
Safety Standards Reference ……………………………………………………………………………………………………….. 6 2.3
Guidance and Manufacturer’s Declaration for EMC
………………………………………………………………………………….7 2.3.1 Important Information Regarding
Electromagnetic Compatibility (EMC) ……………………………………….. 7 2.3.2 EMI Compliance
Table ………………………………………………………………………………………………………………7 2.3.3 EMS Compliance Table
……………………………………………………………………………………………………………..8 2.3.4 Cable Information Provided
Against EMC ………………………………………………………………………………….. 9 2.4 Radio Frequency (RF)
Compliance Information ……………………………………………………………………………………..10 2.5 Radio
Frequency (RF) Energy ………………………………………………………………………………………………………………11 2.6 FCC
Compliance ……………………………………………………………………………………………………………………………….. 11
CHAPTER 3 ABOUT THE PRODUCT ……………………………………………………………………………………………… 12 3.1
Overview ……………………………………………………………………………………………………………………………………………12 3.2 Packaging
Contents ……………………………………………………………………………………………………………………………. 12 3.3 Product
Description ……………………………………………………………………………………………………………………………. 14 3.3.1 Sensor
…………………………………………………………………………………………………………………………………….14 3.3.2 Charging Base
…………………………………………………………………………………………………………………………15
CHAPTER 4 TECHNICAL SPECIFICATIONS ………………………………………………………………………………….16 4.1
Pluto0002XW ……………………………………………………………………………………………………………………………………. 16 4.2 Power
Adapter …………………………………………………………………………………………………………………………………… 17 4.3 Workstation
(Recommended but not Included) ……………………………………………………………………………………….18
v
Pluto0002XW User Manual
Table of Contents
4.4 Router (Recommended but not Included) ……………………………………………………………………………………………….18 4.5 Wireless Communication ……………………………………………………………………………………………………………………..19 4.6 IT Network …………………………………………………………………………………………………………………………………………19
CHAPTER 5 USE ………………………………………………………………………………………………………………………………. 21 5.1 Installing and Removing the AC Plug …………………………………………………………………………………………………… 21 5.2 Charging the System ……………………………………………………………………………………………………………………………21 5.3 Switching ON/OFF the System ……………………………………………………………………………………………………………. 22 5.4 Wireless Connection ……………………………………………………………………………………………………………………………22 5.4.1 AP Mode ………………………………………………………………………………………………………………………………..22 5.4.2 Client Mode …………………………………………………………………………………………………………………………… 22 5.5 Switching Wireless Mode and Restoring to Factory Settings …………………………………………………………………… 23 5.6 Installing Disposable Sanitary Sheaths …………………………………………………………………………………………………..24 5.7 Device Placement ………………………………………………………………………………………………………………………………. 24 5.8 Operating Process ………………………………………………………………………………………………………………………………. 25
CHAPTER 6 SOFTWARE INSTALLATION AND CONFIGURATION ……………………………………………..26 6.1 How to Set up an Operating Environment ………………………………………………………………………………………………26 6.2 How to Launch the iDetector ………………………………………………………………………………………………………………..26 6.3 Communication Configuration …………………………………………………………………………………………………………….. 26 6.3.1 Configuring the AP Mode …………………………………………………………………………………………………………26 6.3.2 Configuring the Client Mode …………………………………………………………………………………………………….28 6.3.3 Modifying the IP Address …………………………………………………………………………………………………………28
CHAPTER 7 USER INTERFACE ……………………………………………………………………………………………………….30 7.1 Home Page …………………………………………………………………………………………………………………………………………30 7.2 Acquire Page ………………………………………………………………………………………………………………………………………31 7.3 SDK Page …………………………………………………………………………………………………………………………………………..33 7.4 Detector Page ……………………………………………………………………………………………………………………………………..34 7.5 Calibrate Page …………………………………………………………………………………………………………………………………….36 7.6 Local File Page ………………………………………………………………………………………………………………………………….. 36
CHAPTER 8 INSTRUCTIONS FOR IDETECTOR ……………………………………………………………………………. 38 8.1 Management of Calibration Templates …………………………………………………………………………………………………. 38 8.1.1 Creating Calibration Templates ………………………………………………………………………………………………… 38 8.1.2 Modifying Defect Calibration Template ……………………………………………………………………………………..41
Pluto0002XW User Manual
vi
Table of Contents
8.1.3 Checking the Validity of Calibration Template
……………………………………………………………………………43 8.2 Acquiring and Saving Image
……………………………………………………………………………………………………………….. 43
8.2.1 Loading Calibration Templates ………………………………………………………………………………………………… 43
8.2.2 Saving a Single Image …………………………………………………………………………………………………………….. 44 8.3
Checking Local Images ………………………………………………………………………………………………………………………. 46 8.4
Firmware Upgrade ……………………………………………………………………………………………………………………………… 47
CHAPTER 9 TROUBLESHOOTING ………………………………………………………………………………………………… 48
CHAPTER 10 SERVICE INFORMATION ………………………………………………………………………………………….. 50 10.1
Product Life ………………………………………………………………………………………………………………………………………. 50 10.2
Regular Inspection ……………………………………………………………………………………………………………………………… 50 10.2.1
Daily Inspection …………………………………………………………………………………………………………………….50 10.2.2
Monthly or Yearly Inspection ………………………………………………………………………………………………….51 10.3
Maintenance ……………………………………………………………………………………………………………………………………….51 10.4
Cleaning and Disinfection …………………………………………………………………………………………………………………… 52 10.5
After-Sales Service …………………………………………………………………………………………………………………………….. 53
vii
Pluto0002XW User Manual
Safety Precautions
Chapter 1 Safety Precautions
This chapter provides safety precautions that you need to know to ensure the safe use of the device.
!
WARNING
Install and operate this device in accordance with all safety laws and regulations applicable to the installation of medical devices in your local area and the instructions in this manual to avoid device damage and personal injury caused by improper installation and operation.
1.1 Operation and Storage Environment
!
WARNING
!
CAUTION
Do not store or operate the system in any of the locations listed below. Ignoring this warning may result in device falling, device malfunction, explosion, fire, or personal injury.
- Close to facilities where water is used 2) Where it will be exposed to
direct sunlight 3) Close to the air outlet of an air-conditioner or
ventilation device 4) Close to a heat source such as a heater 5) Where the
power supply is unstable 6) In a location exposed to strong magnetic fields 7)
In an oxygen-rich environment 8) Where there is flammable, explosive,
corrosive gas, liq-uid, or other substances 9) In a dusty environment 10) In a
saline or sulfurous environment 11) Where temperature or humidity is higher
than the specified operating/storage environment 12) In an environment prone
to freezing or condensation 13) In an area prone to vibration 14) On an
incline or in an unstable area 15) In an area with altitude over 3000 meters
The device must be used only in rooms or areas which comply with all laws and regulations for electrical safety in medical premises, where provisions for safety ground connections are present.
Operate this device at 10~40 and 20%~90% relative humidity, and store it at -20 ~55 and 10%~95%RH.
If the temperature or humidity changes drastically, condensation may form inside the device, causing internal circuit failure. Air conditioners, heaters or ventilation devices can be used to control indoor temperature and humidity.
When condensation is attached to the system, be sure to cut off the power supply and let the device stand for at least 2 hours to make sure it has been acclimated to the temperature and humidity of the environment.
1
Pluto0002XW User Manual
Safety Precautions
Be sure to avoid placing the product in close proximity to other devices which
could produce electromagnetic interference (EMI). Even device which meets the
national emission standards may still affect the function of the system.
Otherwise, the imaging performance of the sensor may be degraded, diagnostic
information of the X-ray image may be lost, or the patient’s radiation dose
may be unnecessarily increased.
Do not move and store this device together with sharp or metal objects.
Failure to do so may result in scratches on the surfaces of the device or
components, or damage to the interfaces.
1.2 Device, Interface, Battery, and Cable
!
WARNING
!
CAUTION
Personnel not authorized by iRay Technology are prohibited to open the device
enclosure.
No modification of this device is allowed. Ignoring this warning may result in
an explosion, fire, or electric shock, which may result in personal injury,
death, or substantial product damage.
Do not connect the sensor to any component or accessory other than iRay’s
original ones. Do not use any type of power adapter and charging base other
than the ones provided with the device. Ignoring this warning may result in an
explosion, fire, or electric shock, which may result in personal injury,
death, or substantial product damage.
Do not modify the adapter cable or subject it to external stress or damage.
Avoid placing anything heavy on the cable, stepping on the cable, pulling the
cable, or subjecting the cable to excessive bending or bundling. Ignoring this
warning may result in cable failure, which may result in personal injury,
death, or product damage.
Do not plug or unplug the power plug with wet hands. Otherwise, electric shock
could occur, resulting in personal injury or even death.
Do not hit or drop the device. If it is subjected to strong vibration, it may
be damaged, and if used without repair, it may cause fire or electric shock.
The adapter plug must be firmly inserted into the grounded AC power socket. If
contact failure occurs, or if metal objects come into contact with the exposed
metal prongs of the plug, fire or electric shock may result.
Do not place the device with sharp or metal objects. Do not press the charging
port on the device and charging base with sharp and metal objects other than
the supplied reset device. Otherwise, the device or charging base may be
damaged.
Be sure to disconnect the power cable by holding the plug or connector, not by
dragging the cable itself. Doing so may result in damage to the cable, leading
to fire or electric shock.
Pluto0002XW User Manual
2
Safety Precautions
NOTE
The device comes partially charged. It is recommended you fully charge it
before the first use to ensure its optimal performance and longevity.
It takes approximately 3 hours to fully charge the device. The specific
charging time may be affected by the battery and remaining battery power
level.
If this device will not be used for a long period of time, make sure to charge
it to 30%~50% every 3 months and 50%~70% every 6 months to maintain its best
performance.
The battery may have expired if it is consumed quickly after being fully
charged. In this case, take the device to the service center authorized by
iRay Technology to replace the battery.
The device and charging base may heat up slightly during charging. This does
not affect the device’s service life or performance.
As battery overcharge is prevented by the device, you can always store it on
the charging base to maintain it at full power.
1.3 Handling of Device Failures and Serious Incidents
!
CAUTION
Turn off the sensor, unplug the adapter immediately, and contact your sales
representative or local iRay dealer if any of the following occurs:
a) When there is smoke, an odd smell, or an abnormal sound b) When the liquid
has been spilled into the device and the charging base c) When the device or
its components has been dropped and is damaged d) When the device fails and
cannot work normally (including acquisition failure,
communication failure, etc.) e) When the image quality deteriorates
significantly
Report to the competent authority in your country/region and iRay Technology
if any serious incident occurs during and after the use of the device.
1.4 Inspection, Cleaning, and Disinfection
!
WARNING
Be sure to turn off the power of the system, and unplug the adapter plug from
the AC outlet when the inspections indicated in this manual are going to be
performed.
Ignoring this warning may result in an explosion, fire, or unknown hazards.
Do not immerse the device in liquids. NEVER use flammable cleaning agents
(e.g. alcohol, ether) and other corrosive liquids (e.g. methanol, benzene,
acid, alkali) to clean the device.
Do not sterilize the sensor using autoclave or UV oven. The sensor must be
repaired by iRay’s authorized personnel only.
Ignoring this warning may result in explosion, fire, electric shock, or
unknown hazards, which may result in severe personal injury, death, or
substantial product damage.
3
Pluto0002XW User Manual
Safety Precautions
!
CAUTION
Make sure that the system’s surface, plug, and port are dry before turning ON
the power.
Otherwise, it may result in fire or electric shock.
For safety reasons, be sure to cut off the power supply when it is not in use,
and never maintain the product while it is in use.
Clean the plug of the power cord periodically by unplugging it from the AC
outlet and remove dust and dirt from the plug, its periphery, and the AC
outlet with a dry cloth.
If the power cord is left plugged in for an extended period in a dusty, dark,
and humid environment, the dust around the outlet will absorb moisture,
possibly causing insulation failure and fire.
Pluto0002XW User Manual
4
Regulatory Information
Chapter 2 Regulatory Information
This chapter depicts the labels attached to the package box, the device, and its accessories, and collects some basic regulatory information.
2.1 Symbols
All symbols shown below are for description and explanation only.
Symbol
Explanation
Indicates “Keep the device upright”
Indicates “Fragile, handle with care”
Indicates “Keep Dry”
5
-10 10%
55 95%
Indicates the maximum number of stacks Indicates the temperature limits to which the product can be safely exposed Indicates the humidity limits to which the product can be safely exposed
Indicates “Keep away from direct sunlight”
Indicates the manufacturer’s 19-digit serial number as shown below: A1A2A3A4
B1B2 C1C2 L M1M2D1D2Y1Y2 X1X2X3X4
Production Series No. Production Date Production Site Production Version No.
Derivative Type Production Type
Indicates the name and address of the manufacturer
EC REP
!
Indicates the name and address of iRay’s authorized representative in the region of the European Union Indicates “Caution! Please refer to the instructions in this manual”
5
Pluto0002XW User Manual
Regulatory Information
Symbol
Explanation
Represents “please follow operating instructions for use”
IP44
Represents “Attention! Consult this user manual for general information”
Indicates that the product must be sent to the appropriate facility for
recycling when the end user intends to discard the product
Represents non-ionized electromagnetic radiation
Indicates the degrees of protection provided by the handle (IP Code) against
solid objects or liquids is
equivalent to IP44
Indicates the device contains BF type applied part
MD
Indicates this product is a medical device
2.2 Safety Standards for Medical Device
2.2.1 Medical Device Classification
Item
Classification
Type of protection against Internally powered device
electrical shock Degree of protection against
Type BF applied part electrical shock
Degree of protection against ingress of water
IP68 (CMOS sensor) IP44 (handle) IP44 (charging base)
Mode of operation
Continuous operation
Flammable anesthetics
Not suitable for use in the presence of a flammable anesthetic mixture with
air or with oxygen or nitrous oxide
Not suitable for use in the oxygen-rich environment
2.2.2 Safety Standards Reference
The safety standards listed below apply to the product and its accessories.
Pluto0002XW conforms to this IEC 60601-1-2:2014 standard on both immunity and
emissions. Use only computers and image display monitors complying with IEC
60601-1 or IEC 60950-1.
Pluto0002XW User Manual
6
Regulatory Information
Standard
Description
IEC 60601-1:2005/AMD2:2020
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014/AMD1:2020
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances Requirements and tests
IEC 60601-2-65:2012
Medical electrical equipment – Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
2.3 Guidance and Manufacturer’s Declaration for EMC
2.3.1 Important Information Regarding Electromagnetic Compatibility (EMC)
Pluto0002XW needs special precautions regarding EMC and needs to be installed
only by iRay or authorization engineers and put into service according to the
EMC information provided in the user manual.
This equipment in use may be susceptible to electromagnetic interference from
portable and mobile RF communications such as mobile (cellular) telephones.
Electromagnetic interference may result in incorrect operation of the system
and create a potentially unsafe situation.
The use of accessories and cables other than those specified by iRay, with the
exception of accessories and cables sold by iRay of Pluto0002XW as replacement
parts for internal components, may result in increased emissions or decreased
immunity of the sensor.
Pluto0002XW should not be used adjacent to or stacked with other devices. In
case adjacent or stacked use is necessary, the sensor should be observed to
verify normal operation in the configuration in which it will be used.
2.3.2 EMI Compliance Table
Electromagnetic Emissions
Emission Test
Compliance
Conducted and radiated RF emissions Group 1
CISPR 11
Class B
Harmonic distortion IEC 61000-3-2
Class A
Voltage fluctuations/flicker IEC 61000-3-3
Complies
Electromagnetic Environment-Guide
Professional healthcare facility environment
7
Pluto0002XW User Manual
2.3.3 EMS Compliance Table Enclosure Port
Regulatory Information
Phenomenon
Basic EMC Standard
Electrostatic Discharge
IEC 61000-4-2
Radiated RF EM field
IEC 61000-4-3
Proximity fields from RF wireless IEC 61000-4-3
communications equipment
Immunity Test Levels
Professional Healthcare Facility Environment
±8kV contact ±2kV, ±4kV, ±8kV, ±15kV air 3V/m 80MHz-2.7GHz 80% AM at 1kHz
Refer to table “Proximity Fields from RF Wireless Communications Equipment”
Rated power frequency magnetic IEC 61000-4-8
fields
30A/m 50Hz or 60Hz
Proximity Fields from RF Wireless Communications Equipment
Test frequency (MHz)
385 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785
Band (MHz)
380-390 430-470 704-787
800-960
1700-1990 2400-2570 5100-5800
Immunity Test Levels Professional Healthcare Facility Environment
Pulse modulation 18Hz, 27V/m FM, ±5kHz deviation, 1kHz sine, 28V/m Pulse
modulation 217Hz, 9V/m
Pulse modulation 18Hz, 28V/m
Pulse modulation 217Hz, 28V/m Pulse modulation 217Hz, 28V/m Pulse modulation
217Hz, 9V/m
Pluto0002XW User Manual
8
Input A.C. Power Port
Phenomenon
Basic EMC Standard
Electrical fast transients/burst
Surges Line-to-line Surges Line-to-ground
IEC 61000-4-4 IEC 61000-4-5 IEC 61000-4-5
Conducted disturbances induced IEC 61000-4-6
by RF fields
Voltage dips
IEC 61000-4-11
Voltage interruptions
IEC 61000-4-11
Signal Input/Output Parts Port
Phenomenon
Basic EMC Standard
Electrostatic discharge
IEC 61000-4-2
Electrical fast transients/bursts
Surges Line-to-ground
IEC 61000-4-4 IEC 61000-4-5
Conducted disturbances induced IEC 61000-4-6
by RF fields
2.3.4 Cable Information Provided Against EMC
Regulatory Information
Immunity Test Levels Professional Healthcare Facility Environment
±2kV 100kHz repetition frequency ±0.5kV, ±1kV
±0.5kV, ±1kV, ±2kV 3V 0.15MHz – 80MHz 6V in ISM bands between 0.15MHz and
80MHz 80% AM at 1kHz 0% UT; 0.5 cycle At 0º, 45º, 90º, 135º, 180º, 225º, 270º
and 315º 0% UT; 1 cycle 70% UT; 25/30 cycles Single phase: at 0º 0% UT;
250/300 cycles
Immunity Test Levels Professional Healthcare Facility Environment
±8kV contact ±2kV, ±4kV, ±8kV, ±15kV air ±1kV 100kHz repetition frequency
±2kV 3V 0.15MHz – 80MHz 6V in ISM bands between 0.15MHz and 80MHz 80% AM at
1kHz
Cable
Recommended Length
DC power cable (adapter) 1m
Shielded/unshielded
Unshielded
Qty.
Classification
1
DC power
9
Pluto0002XW User Manual
2.4 Radio Frequency (RF) Compliance Information
Regulatory Information
Nation
U.S.A
European Union
Item
47 CFR part 15, subpart B 47 CFR part 15, subpart C 15.247 47 CFR part 15,
subpart E 15.407 KDB447498 D01 v06 General Exposure Guidance
EN 55032: 2015 + A11:2020 EN 55035: 2017 + A11:2020 ETSI EN 301 489-1 V2.2.3
ETSI EN 301 489-3 V2.1.1 ETSI EN 301 489-17 V3.2.4 EN IEC 61000-3-2: 2019 EN
61000-3-3: 2013 ETSI EN300 328 V2.2.2 (2019-07) ETSI EN301 893 V2.1.1
(2017-05) ETSI EN300 440 V2.1.1 (2017-03) EN 50566:2017 EN
62209-2:2010+A1:2019 EN 62479:2010
Pluto0002XW User Manual
10
Regulatory Information
2.5 Radio Frequency (RF) Energy
This device is designed and manufactured not to exceed the emission limits for
exposure to radio frequency (RF) energy set by the Federal Communications
Commission of the United States. The exposure standard for wireless devices
employing a unit of measurement is known as the Specific Absorption Rate, or
SAR. The SAR limit recommended by the general public is 1.6W/kg Averaged over
one gram of tissue by IEEE Std 1528. The FCC has granted an Equipment
Authorization for this product with all reported SAR Levels evaluated as in
compliance with the FCC RF exposure guidelines. While there may be differences
between the SAR levels of various product and at various positions, they all
meet the government requirements. SAR compliance for body-worn operation is
based on a separation distance of 0 mm between the unit and the human body.
Carry this device at least 0 mm away from your body to ensure RF exposure
level compliant or lower to the reported level.
2.6 FCC Compliance
FCC ID: 2ACHK-02113698 This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions: This device may not
cause harmful interference. This device must accept any interference received,
including interference that may cause undesired operation. This equipment has
been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the
following measures: Reorient or relocate the receiving antenna. Increase the
separation between the equipment and receiver. Connect the equipment into an
outlet on a circuit different from that to which the receiver is connected.
Consult the dealer or an experienced radio/ TV technician for help. Changes or
modifications not expressly approved by the manufacturer could void the user’s
authority to operate the equipment.
11
Pluto0002XW User Manual
About the Product
Chapter 3 About the Product
This chapter gives an introduction to the device itself, and its packaging
contents.
3.1 Overview
Pluto0002XW is a portable handheld wireless X-ray intraoral sensor based on
complementary metal-oxide semiconductor (CMOS) technology. Using the CsI:Ti
scintillator, it is able to provide high-quality dental diagnostic images for
diagnosis by X-ray medical systems. Its wireless function allows the operator
to efficiently perform dental examinations of patients in any position. The
iDetector can integrate the Pluto0002XW into your DR system, and run on the
workstation with Windows operating system for sensor configuration, image
acquisition, image preprocessing, and image browsing. iDetector allows you to
control the sensor in the absence of a DR system.
Intended Use
The Pluto0002XW works with an adapted intraoral dental X-ray machine for
static digital intraoral X-ray imaging in healthcare institutions. The device
is intended for use by trained and qualified dentists, dental technicians, and
maintenance personnel. It is not suitable for mammography and dynamic imaging
photography. Do not use it on pregnant women.
Key Features
Wireless connection Equipped with an advanced CMOS sensor Provides low-dose
and high-resolution images Ergonomically designed Lightweight and robust
design IP68 IP rating AED trigger available Comes with an SDK, easy to
integrate
3.2 Packaging Contents
The Pluto0002XW system is carefully inspected and packaged prior to shipment.
Upon receipt of the package, be sure to locate each of the system items shown
below.
Pluto0002XW User Manual
12
Sensor (Pluto0002XW) ×1
About the Product Power adapter (switching power supply) ×1
Charging base (Charger-KW) ×1
AC plug (choose 1 pc.) ×1
USB×1
Gain calibration file Defect calibration file SDK Supplied App
Documents×3
OQC Testing Report Packing List Sensor Certificate of Quality
NOTE
The actual packing list of the Pluto0002XW may vary depending on your customization needs or accessories available in your region. Carefully check if the packaging contents match the packing list, and contact your iRay Technology dealer within 24 hours of receipt if any parts are missing or damaged.
13
Pluto0002XW User Manual
3.3 Product Description
3.3.1 Sensor
1
About the Product
2 3
6 4
7 5
8
9
No.
Name
CMOS sensor
STATUS indicator
LINK indicator
POWER indicator
Power button
LED Indicators
LED
Status
STATUS indicator
Off Steady green
Off
LINK indicator
Steady blue
Steady green
Pluto0002XW User Manual
No.
Name
Near field communication region
Handle
Sensor label
Charging port
Figure
FPD Status
Exposure allowed (in idle state) Exposure prohibited (data transfer in
progress) Client mode not built AP mode: wireless AP is ready Client mode:
wireless connection is built
14
LED
Status
Figure
POWER indicator
Operating
Steady orange Flashing orange
Charging
Steady blue Off
3.3.2 Charging Base
1
4
2
3
5
About the Product
FPD Status
Sufficient power (30%~100%) Insufficient power (0%~30%) Charge in progress
Fully charged (100%)
6 7
No.
Name
Drain hole
Charging indicator
Type-C port
Pogo pins
No.
Name
Reset device
Charging base label
Suction cups
15
Pluto0002XW User Manual
Technical Specifications
Chapter 4 Technical Specifications
This chapter covers the drawings and the technical specifications you may need
to better understand this device.
NOTE
Please note that the specifications described below are nominal values that may not exactly match actual values.
4.1 Pluto0002XW
Drawing
Specifications
Item
Model Application Scintillator
Specification
Pluto0002XW Dental intraoral application CsI: TI
Pluto0002XW User Manual
16
Item
Specification
Image sensor Pixel pitch Active area
CMOS 20m 26mm×36mm
Effective pixel matrix ADC
1300×1800 16-bit
Trigger mode AED trigger threshold
AED 50µGy/s
Exposure window time X-ray energy Data/config. info transfer
10ms~3s 55100kV Wireless (2.4G/5.8G Hz)
Max. linear dose
300uGy
Dynamic range
50dB
Recommended operating environment conditions
Temperature: 10~40 Humdity: 20%~90%RH Atmospheric pressure: 700~1060 mbar
Recommended storage & transport conditions
Temperature: -20~55 Humdity: 10%~95%RH Atmospheric pressure: 700~1060 mbar
Dimensions Weight
32mm (L)×31mm (W)×272mm (H) 180g
4.2 Power Adapter
Drawing
Technical Specifications
17
Pluto0002XW User Manual
Specifications
Item
Model Input Output Dimensions Weight
Specification
UES12LCP-050200SPA 100~240V AC input 5V single output,10W 76.0mm (L)×30.3mm
(W)×48.2mm(H) 0.13kg
4.3 Workstation (Recommended but not Included)
Specifications
Item
Operating system CPU Integration software
Requirement
Windows 7, 32/64 bits, or higher Intel Core I5, or higher iDetector
Technical Specifications
!
CAUTION
To avoid unnecessary troubles during the process of system integration, it is
highly recommended to use the workstation configuration certified by iRay
Technology.
Turn off the firewall and anti-virus software to avoid problems such as sensor
connection failure or abnormal images.
4.4 Router (Recommended but not Included)
Item
Frequency range
Recommended router model
Requirement
2.412~2.472GHz: ch1~ch13 5.18~5.24GHz: ch36~ch48 5.745~5.85GHz: ch149~ch165
TP-LINK: TL-XDR3020 ASUA: RT-AC86U NETGEAR: R7000 Mercury: D121 Teada: AC11
Pluto0002XW User Manual
18
4.5 Wireless Communication
Item
Frequency range Security Antenna
Description
2.412~2.472GHz: ch1~ch13 5.18~5.24GHz: ch36~ch48 5.745~5.85GHz: ch149~ch165
WPA-PSK, WPA-WPA2-PSK, WPA2-PSK Built-in dual-band antenna
Technical Specifications
!
CAUTION
The Pluto0002XW is equipped with a wireless transmission function, which can
generate electromagnetic radiation during the operation of the device, and can
also be affected by electromagnetic cross-talk of other electrical equipment
in the environment. Its wireless transmission performance is greatly affected
by the placement of physical obstacles and materials. During use, attention
should be paid to the following aspects:
Positions the router as high as possible above the sensor Reduces the barrier
between the sensor and the router Chooses channels with fewer devices Keeps
the sensor and router far away as possible from strong signal interference
sources such as
motors and transformers
4.6 IT Network
Item
Purpose for IT-network Intended information flow
Frequency Range Security
Description
Transmits image data, commands and status commands between sensor and
workstation
The sensor sends the acquired image data to the workstation, and the
workstation sends user’s instructions to the sensor 2.412~2.472GHz: ch1~ch13
5.18~5.24GHz: ch36~ch48 5.745~5.85GHz: ch149~ch165 WPA-PSK, WPA-WPA2-PSK,
WPA2-PSK
!
WARNING
Connection of the sensor to an IT-network that includes other equipment could
result in previously unidentified risk that should be identified, analyzed,
evaluated, and controlled by the manufacturer of the X-ray machine.
Subsequent changes to the IT network may introduce new risks that require
additional analysis.
19
Pluto0002XW User Manual
!
CAUTION
Changes to the IT network include:
Changes in the IT network configuration Connection of additional items to the
IT-network Disconnecting items from the IT-network Update of equipment
connected to the IT-network
!
CAUTION
Hazardous situations resulting from the failure of the IT network:
Failure of completing essential performance Failure of finishing configuration
of product Operating system is not compatible Change or update software failed
Compatibility of interface Data transfer protocol error Inconsistency of
interface or format leads to data distortion Data output failed
Technical Specifications
Pluto0002XW User Manual
20
Use
Chapter 5 Use
This chapter mainly illustrates how to use the Pluto0002XW system efficiently.
5.1 Installing and Removing the AC Plug
In stallatio n
Install the plug by pushing the AC plug along the edge of the adapter
connector toward the word “PUSH” until fully locked
5.2 Charging the System
R em o val
Press the “PUSH” position with the left hand slightly, and push the AC plug in
the opposite direction with the right hand until it is completely detached
from the connector
1 When the battery is low (less than 30%), insert the Type-C interface of the
adapter into the charging base;
2 Plug the adapter into the AC socket;
3 Place the sensor close to the charging base in the direction shown, and when
the two are close enough, it can be automatically magnetized and connected to
charge. When it is fully charged, the power indicator changes from steady blue
to off.
21
Pluto0002XW User Manual
Use
5.3 Switching ON/OFF the System
Startup
When the equipment is off, press the power button for more than 8s to turn it
on.
Powerdown
When the equipment is on, press the power button for more than 8s to turn it
off.
5.4 Wireless Connection
5.4.1 AP Mode
In this mode, the sensor (Pluto0002XW) itself acts as an AP (wireless access
point), transmitting wireless hotspots, and the connection between the sensor
and the workstation is established via the wireless network transmitted by the
sensor AP.
P luto 0002XW
W o rkstatio n
NOTE
It is recommended to configure the sensor using AP mode and acquire images using Client mode because continuous use of AP mode for a long time may accelerate the power consumption and there is a possibility of packet loss
5.4.2 Client Mode
In this mode, an external device (such as a router) acts as an AP, and the
connection between the sensor (Pluto0002XW) and the workstation (PC) is
established via the wireless network transmitted by the external AP.
Pluto0002XW User Manual
22
Use
P lu to 0002XW
Extern alA P
W o rkstatio n
5.5 Switching Wireless Mode and Restoring to Factory Settings
Mode Switch
Network Factory Reset
-
Remove the reset device of the charging base 1) Remove the reset device of the charging base
-
Insert the central cylinder boss of the reset 2) Insert the central cylinder boss of the reset device into the
device into the central groove of the
central groove of the sensor
sensor
-
Press the reset device, the Link indicator flashes blue first, then
-
Press the reset device and hold it for 3s. Remove it after the Link indicator flashes blue, and the mode can be switched successfully
green, and then removes the reset device. The wireless network of the sensor will be restored to the factory state (restores to AP mode, restores the factory default SSID to PlutoXW, password 12345678)
NOTE
The default factory wireless connection mode is “AP” mode. After each boot, your sensor automatically starts in the wireless mode selected last time.
23
Pluto0002XW User Manual
Use
5.6 Installing Disposable Sanitary Sheaths
S an itary sh eath s
!
CAUTION
To help prevent cross-contamination between patients, place a new sanitary sheath on the sensor for each new patient. Please note that the sheath must cover the CMOS sensor and crank area which may have the possibility of contamination.
5.7 Device Placement
To place your device properly, refer to the following.
X-ray
Sen so r 90°
X-ray
90°
Sen so r
To oth Lo n g axis o fth e to oth
Parallelin g m eth o d
Position the X-ray beam perpendicular to both the CMOS sensor and the long
axis of the tooth to be examined
To oth Lo n g axis o fth e to oth
D iago n alm eth o d
Place the sensor as parallel as possible to the tooth, and direct the X-ray
beam perpendicularly towards an imaginary line that bisects the angle between
the CMOS sensor and the long axis of the tooth
NOTE
Use of a sensor positioning device is recommended to guarantee that the CMOS sensor is positioned at right angles to the X-ray beam and tooth.
Pluto0002XW User Manual
24
Use
5.8 Operating Process
- Place the sensor in the operating environment as described in Section 1.1
Preparation
-
Long press the power button for more than 8s to switch on the equipment 3) Check the battery level to make sure it is sufficient (steady orange )
-
Configure the wireless communication mode (AP /Client )
-
Set the loading factors of the X-ray source (for example, kV, mA, s, etc.)
-
Cover the CMOS sensor and crank area with a disposable protective sheath Exposure 7) Sensor-assisted positioner (not included) is recommended 8) Guide the patient to place the CMOS sensor in their mouth correctly 9) When preparing to shoot, make sure the sensor allows exposure at this time 10) During the shooting, make sure that the patient holds the sensor in a fixed position 11) Apply a new sheath for the next patient
-
Long press the power button for more than 8s to switch off the equipment
End
-
Clean and disinfect the equipment as described in Section 10.4
-
Place the equipment on the charging base
25
Pluto0002XW User Manual
Software Installation and Configuration
Chapter 6 Software Installation and Configuration
This chapter guides you to install the software operating environment and configure the software.
6.1 How to Set up an Operating Environment
SDK Decompressing the SDK
Download the SDK from the supplied CD, and decompress it to a location where
you plan to install it. SDK contains the operating environment installation
files or download path in …Toolsenv_setup.
Microsoft .NET Framework
Locate the SDK Microsoft folder in …/Tools/env_setup/Microsoft/dotnet_setup_url, select the x86 or x64 driver according to the version of your operating system, and install the driver according to the installation prompts.
!
CAUTION
Under the XP environment, bind.txt must be placed in an absolute path.
Visual C++ Redistributable
To ensure the normal use of Visual C++ applications, find the Tools/env_setup/microsoft/vcredist_x64_vs2013.exe. item in the SDK, and install the VC distribution package vcredist_x86_2013 (or vcredist_x64_vs2013) as required.
6.2 How to Launch the iDetector
iDetector, a basic testing tool, can be run immediately with a double-click
without installation, whose SDK path includes: 32-bit system, iDetector.exe
location: …ToolsiDetectorw32 64-bit system, iDetector.exe location:
…ToolsiDetectorx64
6.3 Communication Configuration
6.3.1 Configuring the AP Mode
NOTE
Make sure that the workstation has a wireless card plugged in and the latest version of the wireless card driver installed.
Pluto0002XW User Manual
26
Configuring the AP Mode
1 Click Start < Control Panel< Network
and Internet< Network and Sharing
Center< change adapter settings, open
the local network connection window,
right-click
[WLAN],
click
[Properties], double-click [Internet
Protocol Version 4 (TCP/IPv4)],
check [Use the following IP address],
and enter “192.168.8.188” for the IP
address; “255.255.255.0” for subnet
mask, click [Confirm] to make it take
effect
2 After the sensor is turned on, wait for
the LINK indicator
turns steady
blue, locate the wireless SSID of the
sensor in the workstation wireless
network list, enter the SSID and
password correctly (the default SSID
is PlutoXW, the password is
12345678), click the [Connect]
button, and the AP connection is built
between the sensor and workstation
3 To configure this mode, enter the SDK path …work _dirPluto0002XW Correct, double-click the iDetector icon, connect the equipment, switch to the wifi tab, and check the [AP] mode. On this page, you can modify the SSID and Key, sensor IP address (WLAN IP), security level, frequency, country code, band, channel, etc. and click the [Write Network Config] button to save all the changes you have made
Software Installation and Configuration
NOTE
Make sure that the changed SSID is different from the other existing SSIDs.
27
Pluto0002XW User Manual
6.3.2 Configuring the Client Mode
Configuring the Client Mode
1 After the workstation and sensor are successfully connected in AP mode as
described in 6.3.1, enter the Wifi tab of the Detector page and check the
[Client] mode
Software Installation and Configuration
2 Click the [Add] button, enter the correct SSID and Key of the external wireless AP (such as router) in the popup window, click the [Apply] button, and then click the [Write Network Config] button to add the wireless network
3 After adding the wireless network successfully, select the target wireless network in the network list, click the [Select] button ( appears right before the selected item), and click the [Write Network Config] button. After the sensor successfully connects to the selected wireless network, the Link indicator turns steady green , indicating it is now in the Client mode
6.3.3 Modifying the IP Address
When connecting the sensor for the first time, be sure to set the IP address
of your PC wireless network card to the default 192.168.8.188 to ensure a
normal connection.
Pluto0002XW User Manual
28
Modifying the IP Address
1 After the initial connection, if you need to change the sensor IP address to
187.63.0.8 (examples only) and the workstation address to 187.63.0.9 (examples
only), you need to go to the Detector >Wifi page, change the detector IP
address to 187.63.0.8, and click the [Write Network Config] button
2 Go to the SDK page, change the workstation Host IP to 187.63.0.9, and click
the [Set] button
Software Installation and Configuration
3 Modify the workstation IP address to 187.63.0.9 and click the [OK] button
4 Disconnect iDetector, open the config.ini file under SDK path in …iDetectorx64work_dirPluto000 2XW, and confirm if the values of Cfg_HostIP and Cfg_RemoteIP are correct
NOTE
To ensure a normal connection, be sure that the IP addresses of the workstation and sensor are on the same network segment.
29
Pluto0002XW User Manual
User Interface
Chapter 7 User Interface
This chapter introduces the iDetector user interface and familiarizes you with
its functions. The content displayed on the iDetector interface may vary from
version to version without prior notice.
REFERENCE
For more details, refer to the following files: 903 -341-105_iDetector_UserManual_EN_Ax 903-341-103_SDK_ProgrammingGuide_EN_Ax
7.1 Home Page
Double-click the iDetector icon to run the software, and the home page pops up
as shown below:
Item
Tabs Information bar
Home Acquire SDK Detector Calibrate Local File Name SN Product Type
Description
Connects FPD to PC and checks the PC-FPD connection status Acquires images,
selects calibration modes, saves and processes images Configures Config.ini
parameters and log level Configures FPD parameters and trigger modes Generates
and manages calibration files Opens, views local images, and processes images
Displays FPD name Displays FPD SN Displays FPD model
Pluto0002XW User Manual
30
Item
Buttons
State Connect Close Add Remove Syncbox
User Interface
Description
Displays FPD connection state (bind, unknown, ready, etc.) Connects the
selected FPD Disconnects the selected FPD Adds a working directory Deletes a
working directory Open the Syncbox configuration window (device optional)
NOTE
Except for the Home page and the Local File page, which can be viewed in offline mode, the other four pages can only be viewed when the sensor is connected.
7.2 Acquire Page
Select the corresponding sensor model, and click the [Connect] button on the
home page. When the network connection is normal, the sensor will respond to
the connection command sent by iDetector. After completing a selfcheck,
iDetector will automatically jump to the Acquire page. Acquire page, as shown
below, allows you to perform operations including image acquisition,
calibration method selection, image storage, and processing.
31
Pluto0002XW User Manual
User Interface
Item
Template selection
Image properties
Image list Status bar
Offset
Gain Defect WW WL PosX PosY Value Width Height
SWPreOffset HWPreOffset SWGain SWDefect
FPS
Frames
Mirror ROI
WW/WL
Image List SN State Task Message
Description
The workstation performs PreOffset calibration The sensor performs PreOffset
calibration The workstation performs Gain calibration The workstation performs
Defect calibration Window width Window level X coordinate of the current
cursor location Y coordinate of the current cursor location Gray value of the
current cursor location Image width Image height Acquisition frame rate, keeps
the latest frame rate after stopping acquisition Displays the number of frames
acquired Rotates the image clockwise, 90 degrees every time Rotates the image
anticlockwise, 90 degrees every time Enables or disables the mirror function
of images Checks AVGSVSNR and other image parameters of the selected area
Adjusts WW/WL automatically according to a selection box by performing a
right-click Displays the latest several acquired images, double-click to view
image details Displays the SN number of the currently-connected sensor
Indicates the state of sensor, e.g., busy, ready Displays the task being
executed Indicates feedbacks on result of the sensor action, e.g., succeed,
failed Displays the current battery percentage
Pluto0002XW User Manual
32
User Interface
7.3 SDK Page
Click [SDK] on the home page to enter the SDK page as shown below, which
contains all the parameter information related to the SDK. You can modify some
of the modifiable configuration items according to your actual needs.
Item
Description Definition
Default
Host IP
PC IP address
192.168.8.188
Host Port
PC port
28000
Gain Tmpl Check (day) Validity period of Gain template
180
Defect Tmpl Check (day) Validity period of Defect template
365
Configurable parameters
Cali Tmpl Enable
Default subset
Check
Detects whether the template is invalid
Sets the default subset mode
On Mode1
Clear Acq Delay Time (ms)
Sets the acquire delay time
1000
Allow SN Mismatch
Allows SN mismatch
Off
Timing output
Enables timed output
Off
Retransfer Image Enable
Retransfers the legacy image after Off
restoring the connection
Range
Any valid IP address / / /
On/Off
–
–
On/Off On/Off
On/Off
Buttons
Set
Sets the Log level
LogLevel_Info
LogLevel_Debug LogLevel_Info LogLevel_Warn LogLevel_Error LogLevel_Always
33
Pluto0002XW User Manual
User Interface
7.4 Detector Page
Click the [Detector] tab on the Home page to enter the Detector page. On this
page, you can view the configuration information of the currently connected
sensor, including the SN number, version, and IP address.
Parameters
When entering the Detector page, you will be directed to the Parameters page
by default. The page is mainly divided into three areas: parameter items,
operation buttons, and status bar.
Item
Description Definition
Default Range
Configurable parameters
Set Delay Time (ms) Sets the exposure window delay time
1000
/
Trigger Mode
Sets the trigger mode: Soft (for debugging) AED_DC (for high frequency ray machines) AED_AC (for power frequency ray machines)
AED_DC
Enm_TriggerMode_Soft Enm_TriggerModeAED DC Enm_TriggerModeAED AC
Trigger threshold (uGy/s)
Sets the AED trigger threshold
20uGy
TriggerThreshold_20uGy TriggerThreshold_50uGy TriggerThreshold_100uGy TriggerThreshold_300uGy TriggerThreshold_500uGy
Buttons
Reset Detector
Resets the sensor
Read
Reads the ROM parameters of the sensor
Write
Writes the ROM parameters of the sensor
Write RAW
Writes the RAM parameters of the sensor
Upgrade Firmware Upgrades the firmware
Pluto0002XW User Manual
34
Item
Status bar
User Interface
Description
Definition
Default Range
Provides feedback on the state of the sensor, and the information of parameters read or written
!
WARNING
Wifi
Before modifying some of the configurable parameters on the Detector and SDK pages, be sure to familiarize yourself with the function and range of each one. Misconfiguring some parameters can cause abnormal operation of the sensor.
Tab
Client
AP 35
Item
Add Del Up Down Select SSID List SSID Key Security Frequency Country Band
Description
Adds the SSID and Key of the router Deletes the SSID and Key of the router
Moves up the selected SSID Moves down the selected SSID Sets the selected SSID
as the default connection Provides 10 sets of external WLAN info (double-click
an item to edit information) Enters to modify the SSID of the sensor AP Enters
to modify the Key of the sensor AP Selects an encryption mode from the drop-
down list box Selects 2.4GHz or 5GHz frequency band from the drop-down list
box Selects a country code from the drop-down list box Selects a band from the
drop-down list box
Pluto0002XW User Manual
User Interface
Tab
Client/AP
Item
Channels Read Network config Write Network config WLAN IP Read Wifi Status
Scan from FPD
Description
Selects a channel from the drop-down list box Reads the sensor’s internal
wireless configuration parameters Resets wireless configuration parameters to
the FPD Displays or modifies the sensor IP address Reads the wireless
connection status of sensor Scans the list of available SSIDs in the
environment
7.5 Calibrate Page
Click [Start Generate Template] on the Calibrate page to enter the Creat
Correct Template page (as shown in the figure below) where you can select an
operating mode, and generate and manage calibration templates.
Page
Welcome page Mode Files Create Gain Create Defect
Description
The Create Correct Template page pops up after clicking [Start Generate Templates]
Subset settings
Read Status
Create the Gain calibration template
Activates the selected template of the left list
Create the Defect calibration template
7.6 Local File Page
This page allows you to open locally saved images supporting three file
formats: .raw, .tiff, and .dcm, and to search for local images.
Pluto0002XW User Manual
36
User Interface
37
Pluto0002XW User Manual
Instructions for iDetector
Chapter 8 Instructions for iDetector
This chapter describes how to operate the software.
8.1 Management of Calibration Templates
8.1.1 Creating Calibration Templates
The USB shipped with the sensor contains three calibration files:
File
Path
gain_1300×1800.fac.gn …work_dirPluto0002XWCorrect
gain_1300×1800.gn
…work_dirPluto0002XWCorrectDefault
defect_1300×1800.dft
…work_dirPluto0002XWCorrectDefault
Description
Multi-gain calibration file Without this file, the process of Gain calibration
and single-gain template generation will not possibly proceed
Single-gain calibration file Without this file, it is required to generate a
single-gain calibration template with the help of multi-gain file
Defect calibration file Without this file, it is required to generate a defect
calibration template
NOTE
It is recommended to create or recreate calibration templates when: The sensor is first installed in a DR system Changes occur in system settings or hardware configurations The voltage value of the X-ray tube is changed Every 6 months
Creating Gain and Defect Calibration Templates
1 Copy the multi-gain calibration file (gain_1300×180 0.fac.gn) from the USB
to the path …work_dir Pluto0002XWCorrect
Pluto0002XW User Manual
38
Creating Gain and Defect Calibration Templates
2 Click the [Start Generate Templates] button on the Caliber page to enter the
Mode & Files tab, and click [Read Status] button to get the current template
file status (absent indicates that the template has not been created; vaild
indicates the template has been created and is valid; Invalid means that the
template exists but is invalid)
3 Switch to the [Create Gain] tab to start the Gain template generation
process, click the [Start] button, and the “Initialize to create gain” prompt
appears
4 Adjust the X-ray parameters (exposure time, KV value, etc.) to reach the
suggested kV and expected value, align it with the sensor for exposure, the
sensor will automatically acquire and upload the image, when the image meets
the requirements (the Current Value area is green), click the [Accept] button
to accept this image
Note: the color rendered in the Current Value area: yellow indicates the image
does not meet the requirements but still can generate a template; green
indicates the image meets the requirements; red indicates the image does not
meet the requirements, the template cannot be generated, and the dose must be
modified to reacquire images
39
Instructions for iDetector Pluto0002XW User Manual
Creating Gain and Defect Calibration Templates
5 After the first stage is completed, click the [Generate] button and wait
until the prompt “Tasksucceed: Finish Generation Process” appears in the
status bar, it indicates that the single-gain template has been created
6 Switch to the [Create Defect] tab to start the Defect template generation
process, including 5 stages of image acquisition. Click the [Start] button,
the prompt displaying “Initialize to create defect” appears, adjust the
parameters of the X-ray source to reach the suggested kV (70kV) and Expected
value (4500), the sensor will automatically acquire and upload pictures after
receiving Xrays, and click the [Accept] button when green color appears in the
Current Value area
7 After four more exposures, click the [Generate] button and wait until the
“Tasksucceed: Finish Generation Process” prompt appears in the status bar, it
indicates that the defect template has been created
Instructions for iDetector
Pluto0002XW User Manual
40
Creating Gain and Defect Calibration Templates
8 After the Gain and Defect templates are created, switch to the [Mode&Files]
tab, click the [Read Status] button, and check whether the Gain and Defect
templates exist
Instructions for iDetector
!
CAUTION
A single-gain calibration template can be generated provided that a multi-gain calibration template file (gain_1300×180 0.fac.gn) exists and is stored in the path …work_dir Pluto0002XWCorrect.
PROHIBITED
Try not to inflict vibration during calibration. In case the sensor is moved, a recalibration is required.
8.1.2 Modifying Defect Calibration Template
Modifying Defect Calibration Template
1 Click the [Local File] button on the local file page
41
Pluto0002XW User Manual
Modifying Defect Calibration Template
2 Open a .dft file stored under the path of …ToolsiDetectorx64work_dir
Pluto0002XWCorrectDefault, and the Defect calibration template will be
displayed in the image view area
3 The defect settings window (DefectMapSetWnd) shown on the right will pop up
after the file opens To edit dead points, zoom in on the defect template,
locate a bad point, enter its X&Y coordinates in the point area, click [Add]
to add a dead point, and click [Delete] to delete the dead point
4 To edit a bad line: fill in the coordinates of the starting point and end
point of the bad line in the Line area, click [Add] or [Delete] to add or
delete the bad line, and click [Save] to save the modified Defect template
Instructions for iDetector
Pluto0002XW User Manual
42
Instructions for iDetector
8.1.3 Checking the Validity of Calibration Template
When a template is about to reach the set time threshold after a certain
period, an alarm will pop up, and the status of the template on the software
interface will be changed from “valid” to “invalid” status. You can check the
status of the Template on the Create Correct Template page, Calibrate’s
subpage. “Valid” indicates the selected template exists but is invalid;
“Invalid” indicates the selected template exists but is invalid; “Absent”
indicates the selected template has not been created.
NOTE
To ensure that the template is in the latest state during each acquisition, it
is recommended that you check the validity of the template after it is created
and before image acquisition is performed, to avoid image quality degradation
due to the absence of templates.
You can enable/disable the template validity inspection switch by setting the
Cfg_CaliValidity_Enable parameter in the config.ini file. The value 1 is the
enabled state, and 0 is the disabled state.
8.2 Acquiring and Saving Image
8.2.1 Loading Calibration Templates
Three calibration operations (Offset/Gain/Defect) and two calibration methods (Software/Hardware) are available for Pluto0002XW.
NOTE
The software method is that the workstation completes all the image calibration processes; The hardware method is that the sensor completes all the calibration processes.
43
Pluto0002XW User Manual
Instructions for iDetector
NOTE
Before loading the calibration template(s), make sure that the relevant template file(s) exists under the path. …work_dirPluto0002XWCorrectDefault
Supported Groups of Calibration Options
Group
1
Offset
HWPreOffset
Gain
SWGain
Defect
SWDefect
Description
Uploads images faster
2
SWPostOffset
SWGain
SWDefect
Uploads images slower
Note: Check all three calibration operations of Offset, Gain, and Defect, and the image acquired is fully-calibrated.
8.2.2 Saving a Single Image
After loading calibration templates, adjust the X-ray parameters, align the
X-ray device to the CMOS sensor, the sensor will automatically acquire and
upload the image after detecting the X-rays. You can directly browse to the
currently output image in the central image display area on the interface, or
browse thumbnails in the Image List area. At this time, the sensor enters a
standby state after the image acquisition is completed. To save the image,
click the [Save] button and fill in the saved name and path in the pop-up
dialog box.
Pluto0002XW User Manual
44
Instructions for iDetector
Imaging Direction
See the corresponding relationship between the sensor and its imaging
direction (where is the first-pixel position) in the figure below:
!
CAUTION
Ensure that the sensor has sufficient power (>10%) before exposure. Otherwise,
the sensor may automatically shut down and the image cannot be acquired.
Do not inflict vibration during exposure. Otherwise, it may result in poor
image quality caused by noise.
Do not use the equipment near devices generating a strong magnetic field.
Otherwise, it may cause image noise, artifacts, or incorrect images.
45
Pluto0002XW User Manual
8.3 Checking Local Images
Checking Local Images
1 Click the [Load File] button on the Local File page to choose and open an
image file in .dcm, .dft, .raw, or .tif format from the workstation
2 A file in .tiff or .dft format can be opened directly. When selecting a .raw
format file, the dialog box as shown on the right will pop up and it can be
opened only when the image width and height are input correctly
3 You can use the ROI tool, right-click to select an image area, and view the
AVG, SNR and other properties of the image
Pluto0002XW User Manual
Instructions for iDetector 46
Instructions for iDetector
NOTE
.dcm: image files saved in digital imaging and communication image format.
tiff: header files, including offset/gain/defect calibration method, real-time
frame rate, and
exposure window. .raw: raw image, headerless file. .dft: the image in .dft
format can be played like a movie.
8.4 Firmware Upgrade
!
WARNING
For firmware upgrades could cause malfunction to the sensor, do not operate it on your own but with the support of the after-sales technicians of iRay Technology.
Upgrading Firmware via iDetector
1 Enter the [Parameters] tab of the Detector page and click the [Upgrade Firmware] button to enter the Firmware Upgrade page
2 The Current Version Information area displays the current firmware version. Click [Browse] to select the .ifirm file to be upgraded. After loading the file, the new firmware version will be displayed in the lower information box. Click [Start Upgrade] to start the upgrade. When it is complete, the sensor will automatically restart
NOTE
After the upgrade is complete, be sure to click the [Upgrade Firmware] button under the Detector page and check whether the firmware version has been updated in the Current Version Information area of firmware upgrade page.
47
Pluto0002XW User Manual
Troubleshooting
Chapter 9 Troubleshooting
This chapter illustrates some symptoms that you may face and their possible solutions. If the problems persist even if you perform the solutions listed below, immediately stop operation and contact your local distributor or iRay Technology. Be sure to inform them of the product model, SN, and detailed malfunctions.
NOTE
When a failure occurs in the equipment, you are advised to read the main operation information of the sensor from the log. Either setting cfg_loglevel to 0 in the config.ini file or changing the loglevel to Debug mode on the iDetector SDK interface helps to obtain more detailed command interaction information. Log path: …DetectorDirdetector.log.
No. Failure
1
Unable to boot
Cause
Low battery power
Recommended Solution
Connects the charging base to charge the sensor
Low-power protection designed for equipment
Connects the charging base to charge the sensor
Unable to build a Network failure
2
wireless connection between the sensor
and workstation
Incorrect IP address settings
Firewall blocking
Reconfigures the external AP or replaces the external AP network
Sets the IP addresses of the sensor and workstation to the same network
segment
Turns off the firewall to remove restrictions on the software
X-rays failed to emit X-rays
Reconfigures the X-ray source until it e mits X-rays
The loading factors are too low to reach the AED minimum trigger threshold
Increases the loading factors (mA, kV, s)
3
No image acquired
The loading factors are too high, exceeding Reduces the loading factors (mA, kV,
the maximum AED trigger threshold
s)
The exposure time is too short and the AED Extends the exposure time appropriately
does not detect X-rays
and performs a re-exposure
The CMOS sensor does not receive rays from Adjusts equipment positioning as
the source
described in Section 5.7
4
Blurred acquired
image The patient moved
Prevents patient movement
Pluto0002XW User Manual
48
No. Failure
Cause
The X-ray source moved
5
Image acquired too light
The loading factors are too high
6
Image acquired too dark
The loading factors are too low
Troubleshooting
Recommended Solution
Try to keep the source as still as possible during exposure, and use a tripod
when necessary
Increases the loading factors (mA, kV, s)
Reduces the loading factors (mA, kV, s)
49
Pluto0002XW User Manual
Troubleshooting
Chapter 10 Service Information
This chapter presents the service information, including service life, a checklist of the periodic inspection and maintenance, as well as the contact information of iRay after-sales service department.
10.1 Product Life
The product life is expected to be up to 7 years under proper regular inspection and maintenance.
NOTE
The whole product life cycle is subject to that of the sensor. The manufacture
date of the sensor can be found on the label attached to the equipment, on
which the serial number reveals the exact manufacture date of the sensor. See
the actual label for details.
For other replaceable parts, their replacement will not affect the whole
product life, even if their service life is shorter than that of the sensor.
The main parts required to maintain the functioning of this product will be
stocked for 5 years after the termination of production to prepare materials
for repair.
10.2 Regular Inspection
10.2.1 Daily Inspection
To ensure the safe use of the equipment, perform the following checks on the sensor and its accessories every day before and after use.
Stage
Checklist
Operating environment
Operation
Check the operating environment to ensure that it meets the requirements
described in Section 1.1 and that the temperature difference between the
device and the room does not form condensation
Before startup
Sensor
Check if the sensor is damaged Check if the sensor is clean and dry and if it is covered with a disposable protective sheath
Check if the battery power is sufficient (greater than 30%)
Accessories
Check if accessories are damaged and cable housing is torn
After startup
Patient
Equipment positioning
Check whether the patient is wearing a radiation protection device
Check that the relative position of the equipment, X-ray source, and tooth
meets the requirements described in Section 5.7
Pluto0002XW User Manual
50
Stage
Checklist
After shutdown
LEDs Sensor
Chapter 10 Troubleshooting
Operation
Troubleshooting
Check whether the equipment is powered off normally and all LED indicators are off
Check if the CMOS sensor and crank surfaces are clean and disinfected
10.2.2 Monthly or Yearly Inspection
To ensure good performance and reliability of your equipment, perform the following checks monthly/annually:
Checklist
Battery
Bad points Dark state noise Image uniformity Resolution
Linear
Frequency
Monthly
Yearly Yearly Yearly
Operation
Checks the battery performance to see if it loses power quickly in a short
period
Uses system checker
Detects by resolution map or using the resolution test card Examines the image
gray value to evaluate linear
!
WARNING
Only qualified and authorized service personnel is allowed to remove the covers on the equipment.
10.3 Maintenance
The Pluto0002XW does not require any special maintenance other than regular
cleaning and disinfection.
51
Pluto0002XW User Manual
Troubleshooting
10.4 Cleaning and Disinfection
After the equipment is used, perform the following steps to clean and
disinfect it: 1 Put on single-use PPE gloves; 2 Open the package lid, pull out
a wipe through an opening, and close the lid to retain moisture; 3 Remove the
disposable protective sheath, if there are obvious stains on the sensor, wipe
it clean before
disinfection; 4 Wipe the CMOS sensor and the handle of the sensor from top to
bottom to disinfect them; 5 After cleaning, dispose of the used wipes, gloves,
and sheaths into the medical waste bin; 6 Let the surface air dry.
NOTE
Recommended commercial brands of wipes: Alcohol-Quat solutionPDI Super Sani-
Cloth® Germicidal Disposable Wipes Alcohol-Chloride solutionClinell® Universal
Wipes
If the two wipes above are not readily available in your area, you can make up
your solvent based on the ingredient concentrations below.
Alcohol-Quat solution 0.25% n-Alkyl dimethyl ethylbenzyl ammonium chlorides
0.25% n-Alkyl dimethyl benzyl ammonium chlorides 55.00% Isopropyl Alcohol
Alcohol-Chloride solution 0.5% Benzalkonium chloride 0.5% Didecyl dimethyl
ammonium chloride 0.10% Polyhexamethylene biguanide (PHMB)
Pluto0002XW User Manual
52
!
WARNING
Troubleshooting
Chapter 10 Troubleshooting
The equipment should be cleaned and disinfected before its first use, whenever
the equipment is contaminated, and at the end of each day even when the
sheaths are used.
Prior to cleaning, ensure that the equipment is powered off and removed from
the charging base.
Do not spray the sensor directly with detergent, or immerse it in liquids.
Never use flammable cleaning detergent such as alcohol, ether, and corrosive
liquids such as methanol, benzene, acids, and bases to clean equipment.
10.5 After-Sales Service
CS Dept.: Address: Tel: Fax: Email: Website:
After-Sales Service Department of iRay Technology Co., Ltd. Building 45, No. 1000, Jinhai RD., Pudong New Area, 201206 Shanghai China +86-21-50720560 +86-4008266163-60610 service@iraygroup.com www.iraygroup.com
53
Pluto0002XW User Manual
Manufacturer:iRay Technology Co., Ltd.
Address:
RM202, Building 7, No. 590, Ruiqing RD. Zhangjiang East, Pudong, 201201 Shanghai P. R. China
Tel:
+86-21-50720560
Fax:
+86-4008266163-60610
Website: www.iraygroup.com
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>